I understand that part of it, but there's a lot I
Post# of 153779
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Posted On: 10/20/2020 3:16:52 PM
I understand that part of it, but there's a lot I don't understand, and from my inexperienced perspective, it looks like saving the bureaucracy at the expense of the people.
Why is it that we can't say to people in trial site areas that you are going to be part of the trial, and people outside a trial site area that they will go through the eIND program?
Sure, most people are going to take the eIND rather than roll the dice on placebo, but all that really means is a slow pace of enrollment for the trial. (which we already have), because we can't afford to open hundreds of sites (which the FDA already knew about us).
So the worst-case is that eIND "anecdotal" data builds up faster than placebo-controlled trial data. The actual trial takes a long time to complete, but more lives are saved!
It really makes me mad that we aren't treating this like a pandemic, we are treating it like an outbreak of e.coli.
Save the people first. If eIND was working, there was no reason to stop it, just figure out a way to run it concurrently.
(I'm having a hard time putting this into words, so if I'm not making any sense, I apologize.)
Why is it that we can't say to people in trial site areas that you are going to be part of the trial, and people outside a trial site area that they will go through the eIND program?
Sure, most people are going to take the eIND rather than roll the dice on placebo, but all that really means is a slow pace of enrollment for the trial. (which we already have), because we can't afford to open hundreds of sites (which the FDA already knew about us).
So the worst-case is that eIND "anecdotal" data builds up faster than placebo-controlled trial data. The actual trial takes a long time to complete, but more lives are saved!
It really makes me mad that we aren't treating this like a pandemic, we are treating it like an outbreak of e.coli.
Save the people first. If eIND was working, there was no reason to stop it, just figure out a way to run it concurrently.
(I'm having a hard time putting this into words, so if I'm not making any sense, I apologize.)
Quote:
There is no mechanism to get people into trials when widespread EIND access is available.
Only results of blinded controlled studies lead to EUA or approval.
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